February 12, 2003
03-07
_____________________________
PRODUCT
Wang (R) slice steamed and dried sweet potatoes, Net Wt 6 oz (453g), packaged in a flexible plastic bag. Product of China. Recall # F-179-3.
CODE
Item No. 09054, barcode # 87703 01970.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Samjin America, Inc. DRA Hanmi, Inc., Brooklyn, NY., by a press release on August 6, 2002 and letter dated August 7, 2002.
Manufacturer: Hangzhou Qimentang Vegetable Food Co., Ltd., Jingjiang Town, Xiaoshan City, China. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
50 cases (24 - 16 oz. Packages per case).
DISTRIBUTION
NY, NJ, CT, and MA.
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PRODUCT
Gulf Breeze Brand Pure Honey, packaged in glass jars, net weight 16 ounces (2 lb.) 453g. Recall # F-175-3.
CODE
F2B17, F2B18, and F2B19.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Winn Dixie Stores, Inc., Jacksonville, FL., via email.
Manufacturer: Bessonet Bee Co., Inc., Donaldsonville, LA. FDA initiated recall is complete.
REASON
The product was manufactured in part from honey contaminated with chloramphenicol.
VOLUME OF PRODUCT IN COMMERCE
18 cases pf 24 - 1 lb jars.
DISTRIBUTION
LA and MS.
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PRODUCT
Asian Best brand peeled split mung bean, premium quality, in 14 oz. Clear plastic bags, product of Thailand, 50 bags per carton. Recall # F-180-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Eastland Food Corporation, Columbia, MD., by letter on November 18, 2002. State initiated recall is complete.
REASON
The product contained undeclared tartrazine (certifiable as FD&C Yellow #5).
VOLUME OF PRODUCT IN COMMERCE
259 cartons.
DISTRIBUTION
Nationwide.
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PRODUCT
a) Gift of Nature Caramel Popcorn Rice Cakes, 6.5 oz.
Recall # F-176-3;
b) Gift of Nature Peanut Butter Crunch Mini Rice Cakes,
12/4 oz. Recall # F-177-3;
c) Gift of Nature Apple Cinammon Mini Rice Cakes, 12/4 oz.
Recall # F-178-3.
CODE
a) lot 077SM021;
b) lot 036SM021;
c) lot 281SM011.
RECALLING FIRM/MANUFACTURER
Sonora Mills, Inc., Rancho Dominguez, CA., by letters on April 2, 2002. Firm initiated recall is complete.
REASON
The products did not bear complete ingredient statements.
VOLUME OF PRODUCT IN COMMERCE
Various.
DISTRIBUTION
AR, CA, NJ, NY, and Puerto Rico.
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PRODUCT
a) Methylprednisolone Acetate Injection, Suspension,
40mg/ml, Single dose, Preservative Free, 20 mL vial.
Recall # D-121-3;
b) Methylprednisolone Acetate Injection, Suspension,
80mg/ml, Single dose, Preservative Free, 20 mL vial.
Recall # D-122-3.
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
Urgent Care Pharmacy, Spartanburg, SC., by letters on/about September 17, 2002. Firm initiated recall is complete.
REASON
Microbial contamination.
VOLUME OF PRODUCT IN COMMERCE
a) 145 units;
b) 1283 units.
DISTRIBUTION
CN, MA, NC, SC, VA.
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PRODUCT
a) Caverject (alprostadil for injection), 5 mcg, single
dose vials, Rx only, For intracavernosal use only.
NDC 0009-7212-03. Recall # D-103-3.
b) Caverject (alprostadil for injection), 10 mcg, single
dose vials, Rx only, For intracavernosal use only.
NDC-0009-3778-08. Recall # D-104-3.
c) Caverject (alprostadil for injection), 20 mcg, single
dose vials, Rx only, For intracavernosal use only.
NDC 0009-3701-01 and NDC 0009-3701-96 (Physician
samples). Recall # D-105-3.
CODE
a) Lot Expiration date
31HPU 02/2004.
b) Lot Exp. Date
08HRJ 03/2004;
20HYA 05/2004;
26HPJ 01/2004;
66HCK 08/2003;
80FPM 01/2003.
Foreign Distribution (New Zealand, Hong Kong, Singapore)
HI1577 11/2002;
IC1411 01/2003;
IF1015 04/2003.
C) 04HHP 02/2003;
06HKP 03/2003;
22HHF 01/2003;
33HPU 05/2003;
40HSU 07/2003;
54HDC 11/2002;
58HRY 06/2003;
64HCK 11/2002
66HWS 07/2003;
73JBT 10/2003;
75HDJ 11/2002;
78HFF 12/2002;
84HJT 02/2003;
86HFS 12/2002;
87HFS 12/2002;
Physician Samples:
08HMC 03/2003;
21HHF 12/2002;
57HRY 06/2003;
80HDU 11/2002.
Foreign Distribution (New Zealand, Hong Kong, and Singapore):
IA1289 12/2002;
IB0591 12/2002;
IB1100 12/2002;
IC1410 01/2003;
ID0900 03/2003;
IF0207 03/2003;
II1204 06/2003;
JC1316 01/2004;
JE0747 03/2004.
RECALLING FIRM/MANUFACTURER
Pharmacia Corporation, Kalamazoo, MI., by letters on December 2, 2002. Firm initiated recall ongoing.
REASON
Lack of assurance of sterility for the prefilled diluent syringes packaged for use with the product.
VOLUME OF PRODUCT IN COMMERCE
a) 1,623 units;
b) 35,450 units;
c) 139,081 units.
DISTRIBUTION
Nationwide and Internationally.
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PRODUCT
AVC Suppositories (sulfanilamide) 1.05 grams, 16 vaginal suppositories per box with an inserter, Rx only.
Recall # D-120-3.
CODE
2C01AS, Exp. 04/2003.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fielding Pharmaceutical Co., Maryland Heights, MO., by telephone on October 11, 2002 and Octobr 16, 2002, by fax and letter on October 15, 2002.
Manufacturer: R.P. Scherer, St. Petersburg, FL. Firm initiated recall is complete.
REASON
Stability; product was distributed in a new container closure system without stability data to support expiration dating.
VOLUME OF PRODUCT IN COMMERCE
6,120 boxes.
DISTRIBUTION
Nationwide.
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PRODUCT
Red Blood Cells, Autologous. Recall # B-0199-3.
CODE
Unit LS77618.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI., by telephone on January 23, 2002. Firm initiated recall complete.
REASON
Blood product, which tested repeatedly reactive for the hepatitis B surface antigen (HBsAg), positive by confirmatory (neutralization) test for HBsAg, and repeatedly reactive for antibody to the hepatitis B core antigen (anti-HB-core), was inappropriately distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI
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PRODUCT
Human Tissue for Transplantation of the following types:
a) Achilles Tendon. Recall # B-0564-3;
b) Patella Tendon. Recall # B-0565-3;
c) Fascia Sling. Recall # B-0566-3;
d) Cancellous. Recall # B-0567-3.
CODE
a) Units PBA 56940001-01, PBA 56940002-01;
b) Units PBA 56940003-01, PBA 56940004-01;
c) Units PBA 56940005-01, PBA 56940006-01;
d) Units PBA 56940007-01, PBA 56940008-01,
PBA 56940009-01, PBA 56940010-01,
PBA 56940011-01, PBA 56940012-01.
RECALLING FIRM/MANUFACTURER
LifeLink Tissue Bank, Tampa, FL., by letter dated January 15, 2003. Firm initiated recall complete.
REASON
Tissues for transplantation were processed from a donor who was found to test positive for Hepatitis C Virus (HCV) subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
GA, CA, FL, LA, and Korea.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0366-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0367-3.
CODE
a) LN43493;
b) LN50038.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI., by telephone and letter on March 15, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Aristocort, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI and LA.
***CORRECTION***
Enforcement Report for February 5, 2003, (03-06), the recall listing for Baxter's Sodium Chloride Flush and Heparin Lock Flush Syringes, Recall # Z-456/458-3 has Baxter, Deerfield, IL listed as the manufacturer, the correct manufacturer is Baxter, Nashville, TN.
_____________________________
PRODUCT
Pulmonary heart valve allograft, human tissue for transplantation. Recall # Z-0525-03.
CODE
01-0293HV-02.
RECALLING FIRM/MANUFACTURER
LifeNet, Virginia Beach, VA, by telephone and letter on December 19, 2002. Firm initiated recall complete.
REASON
A heart valve from donor whose sera was found potentially positive for Hepatitis C, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 valve.
DISTRIBUTION
NY.
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PRODUCT
Philips BV 300 Mobile X-Ray System. Recall # Z-0526-03.
CODE
Part numbers 9896 000 06801 and 9806 000 06802 with serial numbers: DBXXXX - all DBXXXX - all DDXXXX - all DEXXXX - all DG0001-DG0129 DH0001-DH0033 DJ0001 - DJ0152 DK0001 - DK 0076.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Bothell, WA.,by letter dated September 27, 2002. Firm initiated recall ongoing.
REASON
The C-bow support can bend and break allowing C-arm to fall from support.
VOLUME OF PRODUCT IN COMMERCE
229 devices.
DISTRIBUTION
Nationwide.
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PRODUCT
Spinal 26 Gauge Quincke with Bupivacaine, Epinephrine, and Lidocaine. Recall # Z-0527-03.
CODE
List No. 3099-20
Lot No. 78-725-Z1, Expiration Date: July 1, 2003.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL., by letters on September 12, 2002. Firm initiated recall ongoing.
REASON
Mis-stenciling on tray. Tray stenciled Saddle Block instead of Spinal.
VOLUME OF PRODUCT IN COMMERCE
2980 units.
DISTRIBUTION
AR, CA, FL, MA, ME, NH, NM, PA, PR.
_____________________________
PRODUCT
a) Restoration #8 HA Hip Stem, Catalog No. 6013-1216;
b) Restoration #8 HA Hip Stem, Catalog No. 6013-1218.
Recall # Z-467-3.
CODE
a) Lot Code: 37778302;
b) Lot Code: 37778401.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Mahwah, NJ., by letter on December 2, 2002. Firm initiated recall ongoing.
REASON
Product mix-up. 16mm stem in a 18mm package.
VOLUME OF PRODUCT IN COMMERCE
6
DISTRIBUTION
FL, Chile and Spain.
END OF ENFORCEMENT REPORT FOR FEBRUARY 12, 2003
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